Performance evaluation of Siemens ADVIA Centaur® enhanced estradiol assay and a split sample comparison with liquid chromatography-tandem mass spectrometry

ObjectivesThe objective of this study was to evaluate the newly developed Siemens ADVIA Centaur® enhanced Estradiol (eE2) assay and compare it with a well-established estradiol liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.Design and methodsThe Siemens eE2 assay was evaluated using the Clinical and Laboratory Standards Institute evaluation protocols. Split patient samples were compared with the eE2 assay, the current ADVIA Centaur E2-6 Ill assay; and LC-MS/MS method by API5000 mass spectrometer.ResultsWithin-run and total imprecision of the eE2 assay demonstrated coefficient of variations of 5.7%, 3.2%, 1.5%, and 10.4%, 7.3%, and 6.8%, at levels of 380, 752, and 2051 pmol/L, respectively. The method comparisons showed: eE2 = 0.903(E2-6 III) –16.2, R2 = 0.938, average bias = − 12.3%; and eE2 = 0.946(LC-MS/MS) + 19.5, R2 = 0.925, average bias: 0%.ConclusionThe Siemens eE2 assay correlates well with LC-MS/MS. This method is reliable, and appropriate for routine clinical laboratory use.

► We evaluated the performance of the ADVIA Centaur® enhanced Estradiol (eE2) assay.
► The Siemens eE2 assay demonstrates good precision, linear range, sensitivity, and accuracy.
► The Siemens eE2 assay correlates well with established LC-MS/MS method.
► This method is reliable, rapid and appropriate for routine clinical laboratory use for samples containing estradiol concentrations over 43 pmol/L.